Kornimate/medical-research-clean huggingface dataset:
lenvatinib for unresectable intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of lenvatinib for patients with unresectable intrahepatic cholangiocarcinoma

lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma.no study has evaluated the efficacy and safety of lenvatinib in unresectable intrahepatic cholangiocarcinoma. thus, the investigators carried out this prospective study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of unresectable icc * patients must have at least one tumor lesion that can be accurately measured according to mrecist criteria. * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: platelet count ≥ 50,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/ l serum albumin ≥ 32 g/l asl and ast ≤ 6 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: intrahepatic cholangiocarcinoma lenvatinib
a study of imc008 for advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: an open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of imc008 in cldn18.2 positive advanced solid tumors.

this study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of imc008 in the treatment of cldn18.2 positive advanced solid tumors. dlts observations will be performed 28 days after imc008 administration. during the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.

Eligibility criteria:
inclusion criteria: * advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer. * tumor tissue samples of subjects expected to be available with positive for cldn18.2 immunohistochemistry. * the expected survival period of the subject is ≥12 weeks. * the subject needs to have at least one target lesion that can be stably evaluated. * the ecog score is 0-1. * subject has adequate organ and bone marrow function * all toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-1. * fertility status : women of childbearing age or men whose sexual partners are women of childbearing age are willing to take medically approved high-efficiency contraceptive measures. * subjects must sign and date written informed consent. exclusion criteria: * pregnant and lactating women. * known history of human immunodeficiency virus infection; acute or chronic active hepatitis b; acute or chronic active hepatitis c. syphilis antibody positive; epstein-barr virus infection; cmv infection. * serious infection that is active or poorly controlled clinically. * uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment. * extensive or diffuse lung metastases or extensive or diffuse liver metastases. * oxygen saturation ≤ 95% without oxygen inhalation. * suffering from other research diseases that may limit their participation in this study. * known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease. * there are heart diseases that need to be treated or hypertension that is poorly controlled by the investigator, poorly controlled after standard treatment type 2 diabetes mellitus. * presence of any cardiac clinical symptoms or disorders. * evidence of significant coagulopathy or other significant bleeding risk. * received systemic steroids equivalent to \>15 mg/ day prednisone cumulatively for more than 3 days within 2 weeks prior to apheresis , excluding inhaled steroids. * prior or concurrent occurrence of other malignancies, with the following exceptions. * subjects who have previously received other gene therapy. * allergic/ intolerance to lymphodepletion regimen or crs treatment drugs or imc008. * subjects with severe mental disorders. * the investigator assessed the subject's inability or unwillingness to comply with the requirements of the study protocol .
clinical evaluation of a cochlear implant system

Conditions: Sensorineural Hearing Loss

Summary: the primary objective of this study is to assess the usability of a cochlear implant system.

measure participant ratings on satisfaction of a cochlear implant system via use of validated and non-validated questionnaires.

Eligibility criteria:
inclusion criteria: 1. eighteen years of age or older 2. at least 6 months experience with a nucleus 24 series or later implant in at least one implanted ear 3. at least 3 months experience with the cp810,cp920 or cp910 sound processor 4. fluent speaker in the language used to assess speech perception performance 5. willingness to participate in and to comply with all requirements of the protocol 6. able to score 30% or more at +15 snr with ci alone on a sentence in babble test exclusion criteria: 1. unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device 2. additional disabilities that would prevent participation in evaluations 3. nucleus 22 implant
treatment reality of tension band wiring and locked plate fixation of the olecranon

Conditions: Olecranon Fracture

Summary: the incidence of the olecranon fracture (of) in adults is around 12 per 100,000 inhabitants per year.1 the anatomical shape of the proximal ulna is largely responsible for the stabilization of the humeroulnar joint and reconstruction is therefore obligatory, but often challenging. surgical treatment of the olecranon fracture is performed using tension band wiring (tbw) or locking plate fixation (lpf) osteosynthesis. it is not yet clear, which procedure is superior for a specific patient. in future, an individualized and objectified assessment of expected general and fracture-specific complications should enable the treatment to be individually adapted to the patient\&#39;s risk profile. this shall prevent complications, unnecessary treatments, and treatment costs. in the project presented here, the reality of care for surgically treated patients with olecranon fractures will be analyzed using routine data collected by the barmer health insurance fund. the aim of the study is to analyze differences in the outcome of patients with an olecranon fracture treated with tbw compared to lpf and to identify independent risk factors for unfavorable course.


Eligibility criteria:
inclusion criteria: * inpatient coded diagnosis of olecranon fracture (icd s52.01) exclusion criteria: * incomplete basic information * incomplete insurance status within two years before index * previous treatment of olecranon fracture * unclear treatment of olecranon fracture * age \&lt; 18 years * coded polytrauma * bone tumors/ bone metastasis * both sides injured or missing information of surgery side

Keywords: olecranon fracture surgical treatment locked plate fixation tension band wiring
translesional assessment of gradients during endovascular therapy

Conditions: Peripheral Arterial Disease; Fractional Flow Reserve; Hemodynamics

Summary: primary objective: to document change in translesional pressure gradients (tlpgs) and ratios (fractional flow reserve) using the navvus rxi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease. secondary objectives: * evaluation of correlation of the abi and tbi and tlpgs at baseline and following endovascular therapy * evaluation of the correlation between the change in wiq, tcoms, wound size and change in tlpgs * evaluation of correlation between lesion severity by qva (mld, % diameter stenosis) and tlpgs * evaluation of baseline mla, mld, plaque burden by intravascular ultrasound (optional) and tlpgs

there are a lack of tools available for the intraprocedural assessment of endovascular procedures for lower extremity peripheral arterial disease. the present study will use the navvus rxi catheter to document changes in translesional hemodynamics obtained with and without hyperemia in patients undergoing directional atherectomy, angioplasty, and/or stenting of femoropopliteal and infrapoplieal lesions.

Eligibility criteria:
inclusions: * age \>18 y/o, undergoing clinically indicated endovascular therapy (balloon angioplasty, stenting, atherectomy or combination) for lower extremity peripheral artery disease (pad) and claudication or critical limb ischemia (cli). rutherford category 2-6. * includes iliac lesions, common femoral, superficial femoral artery, popliteal artery and tibial vessels * a subject can be enrolled more than once (up to a maximum of two total times) for treatment of a staged lesion but must wait at least 6 weeks from the completion of the last study enrollment. exclusions: * no pregnant females * no vulnerable populations (dementia, prisoners, children) * baseline bradycardia (heart rate \<50 beats/min) or hypotension (systolic blood pressure \<90 mm hg) will be excluded from receiving adenosine
multi-centre prospective cohort of childhood leukaemia: determinants of health and quality of life of the patients after treatment for an acute leukaemia during childhood or adolescence - lea

Conditions: Leukaemia During Childhood or Adolescence

Summary: regular advances in cancer treatment have dramatically improved the prognosis of children and adolescents with acute leukemia (al), raising with a great acuity the problem of the late physical side effects, social integration, quality of life of the patients and their family as well as identification of the determinants of these outcomes. large nationwide and international cohorts developed in general population (i4c, epic elf...) are restricted to the study of childhood cancers occurrence. in addition, the national registries (french, european) of childhood cancers are designed to evaluate incidence and mortality, but not to produce individual detailed data on the follow-up and outcome of these children. answering these questions supposes a comprehensive multidisciplinary approach resting on prospective cohorts of cancer survivors, specifically exploring the outcome of these children. these cohorts allow to identify prognostic factors of the health condition and social integration, and to propose adapted strategies of follow-up. the childhood cancer survivor study (ccss), which remains the most important study, only concerns the north-american populations and rests on a self-reported follow-up assessment. in france, the lea study, initiated in 2004 could answer some of these questions, but the representativeness and the size of the population (study initially limited to two areas paca-corsica and lorraine) remain insufficient to study uncommon events. similar approaches are conducted in europe trough the broad collaborative pancare network, to which the lea program is associated.


Eligibility criteria:
inclusion criteria: * respect for the criteria of inclusion in the troop; * 24-month-old survivor of recoil(drop) with regard to(compared with) the diagnosis for the leukaemia aiguës myéloblastiques (lam) and leukaemia aiguës lymphoblastiques ( lal) transplanted in 1st complete forgiveness; or in 48 months of recoil(drop) with regard to(compared with) the diagnosis for the lal not transplanted in first complete forgiveness; * having given his(her,its) agreement to participate in the study; * authorized to participate in the study by the parents(relatives) or the legal representatives, for any minor subject; in the particular case of a minor(miner) become major during the follow-up, a grown-up consent will be collected(taken in). exclusion criteria: * non compliance with the criteria of inclusion beforehand quoted, * initial treatment(processing) realized except 9 participating centers, even in case of moving in in the geographical zones covered by these centers during the phase of treatment(processing) or in the course of follow-up.
the effects of swedish massage and manual lymph drainage on muscle fatigue

Conditions: Muscle Soreness

Summary: 12 healthy men aged 18-30 will be included in the study. participants will be selected from students who regularly train and do active sports at the faculty of sports sciences. all participants will do nordic hamstring exercise. participants will rest for 20 minutes after the nordic hamstring exercise protocol in the first week. in the second week, manual lymph drainage covering the lower extremities will be applied for 20 minutes after exercise. in the third week, a swedish massage covering the lower extremities will be applied after exercise. the exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set. the evaluations of the participants will be repeated 3 times: just before the test, after the test and after the application.


Eligibility criteria:
inclusion criteria: * being male between the ages of 18-30 * doing sports and training regularly * not exercising until 1 week before the study exclusion criteria: * having a previous lower extremity injury * having a neurological problem that prevents exercise * does not have a diagnosed cardiovascular problem

Keywords: manual lympatic drainage swedish massage muscle soreness
impact of the development of pediatric palliative care

Conditions: Primary Brain Tumor

Summary: despite medical advances, cancer remains the leading cause of death by disease in children. brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers. the overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor. the end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals. over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.

the main objective of the study is to compare the occurrence and management of end-of-life symptoms in children who died of a primary brain tumor over 2 periods, in 2009 - 2010 and in 2019 - 2020, followed in the pediatric oncology departments of strasbourg, besançon, dijon, nancy and reims.

Eligibility criteria:
inclusion criteria: * patient less than 17 years of age * suffering from a primary brain tumor * died during the period 2009-2010 or during the period 2019-2020 * follow-up in one of the pediatric oncology departments participating in the study (strasbourg, besançon, dijon, nancy and reims) * absence of refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes. exclusion criteria: * refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes * patient with a brain tumor secondary to another cancer

Keywords: primary brain tumor pediatric palliative care
pressure relief algorithm eval

Conditions: Obstructive Sleep Apnea

Summary: the pra effect on apap therapy pressure study is a randomized, controlled, crossover study in pap-adherent participants with osa. pre-screening is conducted to establish potential eligibility based on regular usage of \> 4 hours/night on patients who use an apap device with a pra mode. participants would then be recruited as described below. for those who sign an informed consent, they will be instructed to use the device for the next 8 days with the pra turned on for four consecutive nights and off for four consecutive nights, but in random orientation. to make sure that the device is not limited to apap range when adjusting to respond to pra, the upper limit will be changed to 20 cmh2o during the study. additionally, only patients who have a current p95 of 8 cmh2o or greater will be eligible so that the maximum pra setting of 3 cmh2o can be used.

the first phase of recruiting for the pra effect on apap therapy pressure study will be done during a single phone contact following an email recruitment. during this call, participants will be explained the study along with risks and benefits and evaluated for inclusion and exclusion criteria. if the participant is eligible to enter the study, they will be sent an electronic informed consent form to sign. once the form is signed and verified, the study can then start that evening, after the participant's device has been set for the study. during both arms of the study, every aspect of operation of the apap devices will be the same as those the patient normally uses, except for the following three things: * apap upper range limit will be set to 20 cmh2o * pra or 3 cmh2o will be either on or off * participants cannot use a v̇-com™ device. participants will randomly be assigned to start with or without pra. once the settings are remotely assigned to the device, the patient will sleep on these settings for four nights, ideally consecutively. after four nights, the pra setting will be remotely switched to the 2nd arm setting (on or off), and median and p95 pressure, usage, ahi, and leak averaged over those four nights will be downloaded. the participant will then use the device with the new settings for an additional four nights, hopefully also sequentially. following the 2nd group of four nights, median and p95 pressure, usage, ahi, and leak averaged over those four nights will be downloaded, the participant will be informed that their involvement in the study is complete, and the device will be remotely set back to the settings it had prior to the study. participants will then receive the compensation credit.

Eligibility criteria:
inclusion criteria: 1. adherent use of ≥ four hours/night over previous 2 months. 2. p95 ≥ 8 cmh2o. exclusion criteria: 1. excessive alcohol consumption (\>14 drinks/week). 2. the use of any illegal drug(s). 3. any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
a study of bpi-7711 capsule in non-small cell lung cancer patients

Conditions: NSCLC

Summary: a randomized, double-blind, positive controlled phase iii study to evaluate the efficacy and safety of bpi-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with egfr mutation

this is a phase iii clinical study, which aims to compare the efficacy and safety of bpi-7711 capsule and gefitinib tablet in the treatment of initially-treated patients with locally advanced or recurrent metastatic with egfr mutation.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer. * the ecog score of performance status is 0-1. * locally advanced or recurrent metastatic nsclc that has never received systemic treatment. * according to recist1.1 criteria, there is at least 1 measurable lesion that has not been previously irradiated. * prior to enrollment, a central laboratory testing report has confirmed that the tumor has one of two common egfr mutations positive that are sensitive to egfr-tki therapy, accompanied with or not accompanied with other egfr mutation, with the exception of exon 20 insertion. exclusion criteria: * previously received systemic treatment for locally advanced or recurrent metastatic cancer. * primary t790m mutation-positive patient. * previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormonal therapy, or any clinically proven active interstitial lung disease. * known active infections such as hepatitis b, hepatitis c, and human immunodeficiency virus. * local radiation therapy is carried out within 1 week; more than 30% bone marrow radiation therapy or extensive radiation therapy is performed within 4 weeks. * ≤ 4 weeks from major surgery or ≤ 2 weeks from minor surgery.

Keywords: egfr mutation egfr tki nsclc
cardiotoxicity of radiation therapy (ctrt)

Conditions: Breast Cancer; Lung Cancer; Mediastinal Lymphomas

Summary: the overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. we will focus specifically on patients receiving photon or proton chest radiotherapy. our broad working hypothesis is that rt induces early, subclinical cv injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening cv function.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy. * patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose. * lung cancer patients treated with definitive intent (greater than or equal to 50 gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. patients receiving concurrent chemotherapy will be allowed. * patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. * ability to read and comprehend english. exclusion criteria: * prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * patients receiving stereotactic body radiotherapy * patients unable to undergo mr imaging will be excluded from the optional mr, but will not be excluded from the main study. * life expectancy less than 12 months * vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners) * patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional mr, but will not be excluded from the main study. * non-diagnostic echocardiography windows